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When Dr. Ed Keystone saw the pain in the faces of his patients,
he believed he could offer them hope. That hope arrived late in 2003,
when Canada began offering pharmaceutical companies one-stop shopping
for world-class rheumatology clinical trials.
It was in the late 1990s when a promising new generation of treatments
for rheumatoid arthritis caught the attention and the imagination of a
rheumatologist at Toronto's Mount Sinai Hospital. Called biologics, this
new avenue of attack on this crippling disease prompted an explosion of
clinical trials to test the effectiveness of the drugs.
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Clarifying the consent process
Patients considering clinical trials can face a daunting task when it comes to deciding whether to participate. "Consumer advocates have voiced their concerns about the language in clinical trial consent forms, which is very complex and often written in legalese, combined with difficult medical terminology," says Linda Bennett, Executive Director of the new Canadian Rheumatology Research Consortium (CRRC).
In an effort to improve the quality of rheumatology clinical trials in Canada, arthritis patients, industry and CRRC will explore ways to ensure that study participants have a clear understanding of all aspects of clinical research. This will improve the recruitment of patients into clinical trials, while ensuring that Canadian patients experience the best clinical trial practices in the world.
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"I realized that Canada had to compete in the world for these clinical trial studies, because we want our patients who are failing with conventional therapies to have access to new therapies that wouldn't ordinarily be available," says Dr. Keystone, who is also the Clinical Director of the Canadian Arthritis Network (CAN), one of the Networks of Centres of Excellence.
To attract the industry-sponsored clinical trials, Dr. Keystone and CAN spearheaded the creation of the Canadian Rheumatology Research Consortium (CRRC). Established in February 2003 with initial funding from CAN, the CRRC is a non-profit corporation in partnership with CAN. It will soon provide pharmaceutical companies with one-stop shopping for world-class rheumatology clinical trials. Dr. Keystone is its Chairman.
While there are clinical research consortia in other areas of medicine, Dr. Keystone emphasizes that the CRRC works uniquely closely with industry. For example, CAN facilitated a meeting with 15 Canadian pharmaceutical companies to assess their needs in a potential new consortium. As the CRRC attracts millions of dollars in additional research and development investment, it will be a significant boon for Canadian pharmaceutical companies.
"We want to do this in partnership with industry," says Dr. Keystone, "and we want industry to win. We want our patients to win. And we want Canadian rheumatology research to win."
Already, 46 clinicians in eight provinces are involved with the CRRC, which became operational in late 2003. The consortium will offer pharmaceutical companies a single budget and a confidentiality agreement to cover all participating trial sites. It will operate on a competitive fee-for-service basis, with revenue going towards arthritis research.
The CRRC is also creating a national, clinical database of rheumatoid patients, providing investigators with unparalleled information for rapid and focused patient recruitment. It will also ensure that Canadian patients across the country are made aware of clinical trial opportunities.
"The partnership between CAN and the CRRC has it all," says Linda Bennett, CRRC's Executive Director. "It engages basic scientists, academic and community-based rheumatologists, arthritis patients and industry partners. It really does bring together all stakeholders with an interest and expertise in rheumatoid arthritis."
The CRRC will not only improve the efficiency of rheumatology research in Canada. It will also improve its quality through site quality assurance and an accreditation system for all its investigators and site coordinators, a first for any Canadian consortium. The wealth of clinical expertise within CRRC will help basic scientists in their efforts to further understand the disease.
Rheumatoid arthritis is a painful inflammatory joint disease, affecting some 300,000 Canadians, two-thirds of them women. Half of those who develop the disorder can no longer work within 10 years of its onset.
www.arthritisnetwork.ca
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